Bharat Biotech’s COVAXIN gets approval for phase I & II human trials

Indigenous Covid-19 vaccine joins the race

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Bharat Biotech
Bharat Biotech's Covaxin Covid-19 vaccine gets DCGI approval for phase I and II human clinical trials

Hyderabad-based Bharat Biotech has successfully developed COVAXIN, India’s 1st vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in Genome Valley, Hyderabad, India.

According to the press statement, the Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare granted permission to initiate phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

Announcing the vaccine development milestone, Krishna Ella, chairman, and managing director said, “We are proud to announce COVAXIN, India’s first indigenous vaccine against Covid-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

Speaking about Bharat Biotech’s prowess, Suchitra Ella, joint managing director said, “Our ongoing research and expertise in forecasting epidemics has enabled us to manufacture a vaccine for the H1N1 pandemic successfully. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.”

Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya, and Zika.

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